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Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859284
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Mona Mounir Ibrahim Hassan, Cairo University

Brief Summary:
With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Condition or disease Intervention/treatment Phase
Dental Restoration Failure Other: flowable resin composite Other: self adhering flowable Other: self adhering flowable with adhesive Not Applicable

Detailed Description:
flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 1, 2022

Arm Intervention/treatment
Active Comparator: flowable resin-composite

3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites.

other names: ''flowable composite ''

Other: flowable resin composite
gold standard
Other Name: conventional flowable composite

Experimental: self-adhering flowable
intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system
Other: self adhering flowable
moist bonding self adhering flowable composite
Other Name: embrace wet bond

Experimental: self-adhering flowable with adhesive
intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance
Other: self adhering flowable with adhesive
moist bonding self adhering flowable composite with the aid of an adhesive system.
Other Name: embrace wet bond with adhesive




Primary Outcome Measures :
  1. Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes [ Time Frame: Change from the baseline at 6 months and12 months] ]

    Biological properties (Postoperative hypersensitivity & tooth vitality, Recurrence of caries, erosion & abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral & general health).

    Esthetic properties (Surface luster, Staining (surface &margin),Color match & translucency & Esthetic anatomical form).

    Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour &wear (quantitatively & qualitatively), Proximal anatomical form(contact point &contour), Radiographic examination(when applicable) &Patient's view

    For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory & poor).

    Subscales will not be combined




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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with anterior cervical carious lesions.
  • Pulp asymptomatic vital carious anterior teeth.
  • Co-operative patients approving to participate in the trial.

Exclusion Criteria:

  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Heavy smokers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859284


Contacts
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Contact: mona mounir, msc 01001171585 monamounir1987@gmail.com
Contact: hussein gomaa, PhD drgomaadent@hotmail.com

Locations
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Egypt
Faculty of Dentistry Cairo University Recruiting
Giza, Egypt
Contact: faculty of dentistry         
Sponsors and Collaborators
Cairo University
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Responsible Party: Mona Mounir Ibrahim Hassan, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03859284    
Other Study ID Numbers: Mon15
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No